100. IRB Statement of Compliance *NEW 08/2020*
101. About the IRB *NEW 08/2020*
102. IRB Member Confidentiality
103. Federalwide Assurance/IRB Registration
104. IRB Review Process *NEW 08/2020*
106. InfoEd 21 CFR Part 11 Statement
107. Scientific Methodological Review
108. Expedited Categories
109. Medical Devices *NEW 11/2019*
110. Sponsor - Investigator Research Requirements (When a CU investigator holds the IND) *NEW 11/2019*
111. Guidelines for Genetic Research
112. Recruiting Research Participants
113. Exempt Research
114. External Studies
115. Vulnerable Research Populations
117. Informed Consent, Permission, Assent
119. Unanticipated Problems involving risks to participants or others
120. Continuing Review/ Project Termination
121. Modifications of Approved Research
122. Human Subject Research Education Program
123. Review of Human Subject Research Activities by other Creighton University Committees
124. Additional Department of Defense Requirements
125. Registering with Clinical Trials
126. Engaged in Research
127. Emergency Use of Unapproved Drugs/Devices/Biologics
128. Expanded Access to Investigational New Drugs
131. Data and Safety Monitoring Plans
133. Reportable New Information
134. Suspensions and Terminations
135. Multi-Site
136. Certificate of Confidentiality
Policies have been revised to reflect the Revised Common Rule. The U.S. Department of Health and Human Services and fifteen other Federal Departments and Agencies have issued final revisions to the Federal Policy for the Protection of Human Subjects (the Common Rule). The Final Rule was published in the Federal Register on January 19, 2017 and effective July 19, 2018. It implements new steps to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators.
